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Oral Fecal Microbiota Transplantation in Pediatric Ulcerative Colitis

NCT05202990 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2026-05-06

No results posted yet for this study

Summary

The purpose of this study is to evaluate whether FMT by frozen stool capsules in pediatric UC patients in remission after corticosteroid treatment, can modify their dysbiotic gut microbiota by increasing the richness of their microbiota at 6 months.

Conditions

  • Pediatric Ulcerative Colitis in Remission

Interventions

DRUG

Fecal Microbiota Transplantation by Stool capsules

After colon cleansing using PolyEthylen glycol, the patient will have a colonoscopy under general anaesthesia. The patient will then receive orally FMT (frozen stools capsules prepared from healthy donor feces).

DRUG

Fecal Microbiota Transplantation by Intra-rectal enemas

After colon cleansing using Polyethylen glycol, the patient will have a colonoscopy under general anaesthesia. The patient will then receive first FMT (frozen preparation of stools) by infusion in caecum during colonoscopy and the second and third doses by enemas.

Sponsors & Collaborators

  • MRSU 938 - Research Center of Saint Antoine

    collaborator UNKNOWN

  • URC-CIC Paris Descartes Necker Cochin

    collaborator OTHER

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Bénédicte PIGNEUR, MD, PhD · AP-HP - Department of Pediatric Gastroenterology Hepatology and Nutrition - Necker - Enfants Malades Hospital

  • Harry SOKOL, MD, PhD · AP-HP, Department of Gastroenterology and Nutrition - Saint Antoine Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2028-07-01
Completion
2028-10-01

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05202990 on ClinicalTrials.gov